To explore whether dietary supplementation with a version of Anatabloc(R) exerts an effect on blood levels of amyloid beta (Aβ), or impacts global or functional measures of Alzheimer's Disease (AD) in subjects with mild to moderate AD.

3-Month, Single Site or Multi-Site, Double Blind, Randomized, Placebo-Controlled, Parallel-Group Trial to Evaluate the Safety Tolerability and Potential Effects of the Dietary Supplement Anatabloc(R) in Subjects With Alzheimer's Disease

Study product, as mint-flavored lozenge (3 mg anatabine per lozenge) to be taken 2-3 times each day

Dietary Supplement: Anatabloc(R)

Dietary supplement Anatabloc(R), as a mint-flavored lozenge, to be taken 2-3 times each day

Placebo Comparator: Placebo

Placebo, as mint-flavored lozenge, to be taken 2-3 times each day

Dietary Supplement: Placebo

Placebo, as a mint-flavored lozenge, to be taken 2-3 times each day

Eligibility

Ages Eligible for Study:

65 Years to 90 Years

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

At least 65 years old.

Have a diagnosis of probable AD or a concurrent diagnosis of probable AD and possible or probable vascular dementia.

Score 16 or more on the Mini-Mental State Examination (MMSE).

Otherwise stable medical history and general health.

Weigh between 45 kg and 120 kg inclusive.

Exclusion Criteria:

Have contra-indications, allergy, or sensitivity to the study products or their components.

Be currently taking any of the following medications: systemic (oral or injectable) glucocorticoids; interferon-alpha; anti-CD20 antibody (e.g., rituximab); or anti-CTLA-4 antibody (e.g., ipilimumab).

Be a current smoker or smokeless tobacco user.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01669876